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NCT03710876 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma
A Phase 3 study of Malignant Pleural Mesothelioma, sponsored by Ferring Ventures Limited.
- Active
- Registry status
- Phase 3
- Development phase
- 53
- Enrollment target
- 20
- Study locations
NCT03710876: Active Phase 3 study of Malignant Pleural Mesothelioma, sponsored by Ferring Ventures Limited.
NCT03710876 is a Phase 3 study of Malignant Pleural Mesothelioma that is active but no longer recruiting, run by Ferring Ventures Limited. The registered enrollment target is 53 participants, below the 81-participant average among 6 other Malignant Pleural Mesothelioma trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03710876, a Phase 3 study of Malignant Pleural Mesothelioma, is active but no longer recruiting, sponsored by Ferring Ventures Limited.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 53 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen. Eligible patients will be randomized 1:1 to either: 1. Treatment group: rAd-IFN + Celecoxib followed by Gemcitabine 2. Control group: Celecoxib followed by Gemcitabine Patients randomized to the treatment group will receive rAd-IFN administered into the pleural space via an Intrapleural catheter (IPC) or similar intrapleural device on study Day 1. The primary objective of this study is to compare the overall survival (OS) associated with rAd IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM
Primary Outcome
Time to death (from any cause) from randomization
Conditions Studied
Interventions
- DRUG Gemcitabine
- BIOLOGICAL rAd-IFN
- DRUG Celecoxib Oral Product
Study Locations (20)
Other
- Institut Bergonie - Bordeaux
- CHRU de Brest - Hopital Augustin Morvan - Brest
- CHU de Caen - Hopital Cote de Nacre - Caen
- CHRU de Lille - Lille
- Institut Curie - Oncologie Medicale - Paris
- Centre Hospitalier Lyon Sud - Pierre-Bénite
- CHU de Nantes - Hôpital Nord Laennec - Saint-Herblain
- Evangelisches Krankenhaus Hamm - Hamm
- Universitatsklinikum Regensburg - Regensburg
California
- University of California, Los Angeles (UCLA) - Medical Center - Los Angeles
- University of California, San Francisco (UCSF) - San Francisco
Maryland
- Marlene & Stewart Greenbaum Comprehensive Cancer Center - Baltimore
- University of Maryland Medical Center - Baltimore
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Minnesota
- Masonic Cancer Center - University of Minnesota - Minneapolis
Pennsylvania
- University of Pennsylvania Abramson Cancer Center - Philadelphia
New South Wales
- Chris O'Brien Lifehouse - Camperdown
Victoria
- Monash Medical Centre - Clayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2019-01-21 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
What the registry record for NCT03710876 still lists
NCT03710876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 81-participant average among 6 other Malignant Pleural Mesothelioma trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Malignant Pleural Mesothelioma appearing as the primary indexed condition, and to 3 interventions - of which Gemcitabine is the first listed.
NCT03710876 names 20 study sites across 10 states, led by Other, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT03710876 about?
NCT03710876 is a clinical study titled "Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma". This study will evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 ...
What is the current status of trial NCT03710876?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2019-01-21. Estimated completion is 2026-04.
What conditions does trial NCT03710876 study?
This clinical trial studies the following conditions: Malignant Pleural Mesothelioma.
What interventions are being tested in trial NCT03710876?
The interventions under investigation include: Gemcitabine (DRUG), rAd-IFN (BIOLOGICAL), Celecoxib Oral Product (DRUG).
Who is sponsoring clinical trial NCT03710876?
This trial is sponsored by Ferring Ventures Limited, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03710876 being conducted?
This trial has 20 study locations across California, Florida, Maryland, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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